Senior Quality Validation Engineer

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job title : Senior Quality Validation Engineer

Location : Lessines, Belgium

About the role:

You are part of the Quality Validation department and part of a dynamic team working on the strategic projects of Takeda Lessines.

As Quality Validation Engineer, you perform the quality oversight of the qualification and validation activities related to product, process, cleaning, equipment, facilities, utilities, material, shipping, DD&T (Data, Digital & Technology) and computerized systems. It includes requalification and periodic review as well.

How you will contribute:

• Quality oversight and active quality support for validation and revalidation activities at the site.
• Participate in the elaboration of the validation strategy for projects of different sizes.
• Review/approve validation documentation (Risk Assessments, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Process Performance Qualification, etc.) and associated specification documents (User Requirements Specifications, Functional / Design Specifications).
• Review/approve periodic evaluation maintaining the accurate validation state of processes, equipement, facilities and systems ensuring compliance to procedures and regulatory requirements.
• Review/approve validation incidents and CAPA.
• Ensure validation compliance with intern local and global procedures, regulatory requirements, and guidelines/standards and in collaboration with the project validation teams.
• Provide support and expertise in interpreting policies, regulatory regulations, and internal regulations to assure validation compliance. Provide guidance with support of Quality Validation Manager.
• Communicate effectively at all levels within Quality organization, as well as cross functionally with departments and sites.
• Support risk analysis activities. Demonstrate proficiency in applying risk management tools and practices for the validation activities.

Education and Experience Requirements:

• Bachelor’s – master’s degree in engineering, chemistry, biology, or related discipline.
• At least 5 years’ experience in Quality or related field in the pharmaceutical industry.
• A solid understanding of pharmaceutical quality management systems and regulations including current GxPs. Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections. Experience in Cleaning Validation or Computerized Systems Validation, knowledge in AI/Deep Learning technologies would be a plus.

Key Skills, Abilities, and Competencies:

• Fluent in written and spoken French and English.
• Personal accountability for results and integrity. Critical thinking, analytical, deal with ambiguity and problem solving skills.
• Demonstrated ability to work autonomously and to take decisions within the scope of her/his responsibilities.
• Develop and maintain strong relationships with stakeholders, fostering teamwork and collaboration.
• Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively.
• Strong organizational skills.
• Assertiveness.
• Flexibility.

Find out more about us:

At Takeda, we want to improve patient health through the development of new specialty pharmaceuticals and through better patient support programmes. Takeda is a patient-focused company that will inspire and develop you through work that can change your life.

As a Global Top Employer, Takeda offers challenging careers, encourages innovation and strives for excellence in everything we do. We foster an inclusive and collaborative workplace, where our teams are united by an unwavering commitment to providing better health and a better future for people around the world. 

Empowering our employees to shine:

Takeda is proud of its commitment to having a diverse workforce, offering equal employment opportunities to all employees and applicants regardless of gender, age, nationality, origin, religion, belief, disability, sexual orientation, gender identity or lifestyle, marital or other status. At Takeda, we embrace diversity in its entirety.

Locations

Worker Type

Worker Sub-Type

Time Type